1. Overview of the FDA Initiative on Obesity FDA Science Board April 22, 2004 Robert E. Brackett, Ph.D. Director, Center for Food Safety and Applied Nutrition

2. Background Overweight and obesity increase the risk of coronary heart disease, Type 2 diabetes, and certain cancers. According to some estimates, at least 400,000 deaths each year may be attributed to obesity related conditions.

3. Background Total economic cost of obesity in the United States is about $117 billion per year.

4. Background FDA’s Obesity Working Group (OWG) –Created on August 11, 2003 by Commissioner McClellan

5. Background Charge –Prepare a report that outlines an action plan to cover critical dimensions of the obesity problem from FDA’s perspective and authorities.

6. Obesity Working Group Met 8 times Received briefings from several invited experts from DHHS including CDC and NIH One public meeting One workshop Two roundtable discussions Solicited comments on obesity-related issues (Docket No. 2003N-0338)

7. OWG Report Provides a range of short and long-term recommendations to address the obesity epidemic. Based on scientific facts Addresses multiple facets of the obesity problem under FDA’s purview

8. OWG Recommendations Developing appropriate and effective consumer messages to aid consumers in making wiser dietary choices Establishing educational strategies and partnerships to support appropriate messages and teach people, particularly children, how to lead healthier lives through better nutrition

9. OWG Recommendations Pursuing improvements to the labeling of packaged foods with respect to caloric and other nutrition information Encouraging and enlisting restaurants in voluntary, collaborative efforts to combat obesity and provide nutrition content information to consumers, including calories, at the point of sale

10. OWG Recommendations Facilitating the development of new therapeutics for the treatment of obesity Designing and collaborating with others in effective research in the fight against obesity Involving stakeholders continuously throughout these various processes

11. OWG Report Conclusions The problem of obesity in America has no single cause. –Result of multiple factors acting together over time, including genetic and environmental factors. No single solution to the problem of obesity. –Current trends will be reversed only as a result of coordinated, complementary efforts from a variety of sectors of society.

12. OWG Report Conclusions The obesity epidemic will not be solved quickly. –Any long-lasting reversal of this phenomenon will itself be a long-term process.

13. OWG’s Work - Updates National Policy Dialogue (Dr. Rulis) Therapeutics (Dr. Orloff) Obesity Research (Dr. Acheson)